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`Page 1
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` THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`COALITION FOR AFFORDABLE DRUGS VIII LLC
`Petitioner
`v.
` THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
`_____________________
`Case IPR2015-01836
`U.S. Pat. No. 7,932,268
`Case IPR2015-01835
`U.S. Pat. No. 8,618,135 B2
`________________________
`
`Deposition of Daniel J. Rader, MD
`Philadelphia, PA
`Tuesday, August 23, 2016
`
`Reported by: Jennifer Billstein-Miller
`Job No: 111717
`
`TSG Reporting - Worldwide 877-702-9580
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`CFAD Exhibit 1055
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`
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`Page 2
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`A P P E A R A N C E S:
`MCNEELY HARE & WAR
`CHRISTOPHER CASIERI, ESQUIRE
`12 Roszel Road
`Princeton, NJ 08540
`Counsel for Petitioner
`
`GOODWIN PROCTER
`WILLIAM JAMES, ESQUIRE
`901 New York Avenue, N.W.
`Washington, D.C. 20001
`Counsel for Patent Owner
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` DANIEL J. RADER, M.D.
` - - -
` P R O C E E D I N G S
` - - -
` DANIEL J. RADER, M.D., after
` having been first duly sworn, was
` examined and testified as follows:
` - - -
` E X A M I N A T I O N
` - - -
`BY MR. CASIERI:
` Q. Good morning, Dr. Rader.
` A. Good morning.
` Q. Have you ever had your deposition
`taken before?
` A. No.
` Q. Okay. Just in case your attorney
`here didn't go through the basics, which I'm
`sure he did, I'm going to ask questions, you'll
`give the answers and the Court Reporter will
`take down the answers.
` A. Uh-hum.
` Q. The Court Reporter can't really see
`you shaking your head yes or shaking your head
`no, so it's hard, but if you can try to
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` DANIEL J. RADER, M.D.
`remember to verbalize your answers.
` A. Sure.
` Q. And I have trouble hearing yeahs and
`nos, so if you can try to articulate those two.
` A. Sure.
` Q. And then if you need a break at any
`time, just let me know, and you can have a
`break.
` A. Okay.
` Q. And I'll try to make my questions as
`clear as possible, but if you don't understand
`a question, let me know; otherwise, I'm going
`to assume that you do understand the question.
` A. Okay.
` Q. That's pretty much it.
` So let's get started here. I'm
`going to hand you what's been marked Penn
`Exhibit 2026. It's titled Declaration of
`Daniel Rader.
` Just take a quick look at that.
`And I'm just going to ask you to turn to the
`back page. And if you would, confer for me
`that your signature?
` A. It is.
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` DANIEL J. RADER, M.D.
` Q. Okay. So what we're just going to do
`is go through this, probably not every
`paragraph, but I'll just start off by just
`pointing you to a paragraph and I'll ask you
`some questions about it.
` A. Sure.
` Q. So why don't you turn to paragraph
`number two on page two.
` A. Yes.
` Q. Okay. You indicate here that, I'm a
`medical doctor with over 25 years of experience
`treating patients with a focus on treating
`patients suffering from lipid disorders.
` A. Uh-hum.
` Q. Do you see that?
` A. Yes.
` Q. When did you start treating patients?
` A. I graduated from medical school in
`'84, did a residency in internal medicine, and
`I completed in '88, and then I did further
`training in lipid disorders starting in '88.
` Q. And do you still treat patients today
`for lipid disorders?
` A. I do.
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` DANIEL J. RADER, M.D.
` Q. In the interim between now and 1988,
`were you always treating patients for lipid
`disorders?
` A. Yes.
` Q. Are you a cardiologist?
` A. No, I'm an internist.
` Q. Let's turn to paragraph 12. Today,
`I'm going to jump into the middle of a lot of
`these paragraphs.
` A. Sure.
` Q. But you're free to read the entire
`paragraph if you want. If you need to take a
`minute to read it, just let me know, and you
`can have that; otherwise, I'll just jump in
`where I need to.
` In paragraph 12, right in the
`middle there -- actually, let's start at the
`end -- you indicate, in my practice, I
`regularly treat patients with
`hypercholesterolemia with these types of drugs
`in addition to a suggested regiment of low fat
`diet and regular exercise; do you see that?
` A. Yes.
` Q. And these types of drugs, you're
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` DANIEL J. RADER, M.D.
`talking about statins and fibrates?
` A. And ezetimibe, the ones that are
`listed above.
` Q. Is ezetimibe a different class of
`drugs?
` A. Different class, yes.
` Q. Do you know when you started to treat
`patients with statins?
` A. Statins, if memory serves, came out
`in I believe 1988, so started using them
`shortly thereafter.
` Q. And fibrates, how long have you been
`treating patients with fibrates?
` A. Fibrates are relatively old drugs, so
`I would also say since, you know, I started
`treating with patients with lipid disorders,
`'88 or so.
` Q. How about ezetimibe?
` A. Again, ezetimibe came to the market
`roughly a decade or a little more than a decade
`ago, so I don't know the exact year, but it
`would have been mid -- mid-2000.
` Q. Is there any other drug that you
`would regularly treat patients with
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` DANIEL J. RADER, M.D.
`hypercholesterolemia?
` A. I use a class of medicines not listed
`here called bile acid sequestrants.
` Q. What are those?
` A. What are the names of the drugs?
` Q. Yeah, can you just repeat it for me.
` A. Bile acid sequestrants.
` Q. Any other drugs that you regularly
`treat patients with hypercholesterolemia?
` A. In the past, I've used niacin, but we
`don't use niacin much any more.
` Q. Would you say you can satisfactorily
`treat patients with hypercholesterolemia with
`one or more of these drugs?
` MR. JAMES: Objection to the
` form.
` You can answer the question if
` you understand it.
` THE WITNESS: Can you repeat the
` question? I just want to make sure I
` understand it.
`BY MR. CASIERI:
` Q. Yeah. Can you say you can
`satisfactorily treat patients with
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` DANIEL J. RADER, M.D.
`hypercholesterolemia with one or more of these
`drugs?
` MR. JAMES: Same objection.
` THE WITNESS: It's a pretty
` generic question. There are many patients
` who can't be treated satisfactorily with
` these -- with these drugs.
`BY MR. CASIERI:
` Q. Why not?
` A. They have a high level of cholesterol
`that can't be successfully treated with the --
`with the existing medications or they don't
`tolerate the existing medications.
` Q. And what do you do for those
`patients?
` A. Now or historically or what, give me
`a time frame?
` Q. Okay. Well, let's start with now,
`what do you do with those patients now?
` A. There's a new class of drugs that got
`approved a year ago called the PCSK9
`inhibitors. So that's one option, new option
`for such patients. Patients with HoFH
`specifically, very specific condition, can be
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` DANIEL J. RADER, M.D.
`treated with lomitapide or mipomersen, two
`approve drugs for that condition.
` Q. You mentioned HoFH. Just so we're
`clear, we're talking about the same thing,
`that's an acronym?
` A. That's an acronym for homozygous
`familial hypercholesterolemia.
` Q. And so you'll understand if I say
`HoFH that we're talking about?
` A. I will.
` Q. Okay. Can you treat patients with
`HoFH with PCSK9 inhibitors?
` A. You can try. In general, they're not
`all that effective, although in the subset of
`patients, they may have some effect.
` Q. Now, earlier, when you said there
`were, I guess, a class of patients who had a
`high level of cholesterol or don't tolerate the
`drugs, the statins or the sequestrants, were
`you specifically talking about patients with
`HoFH, or were you talking about more than just
`patients with HoFH?
` A. No, that wasn't specific to HoFH.
` Q. So would it be fair to say some
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` DANIEL J. RADER, M.D.
`patients with, I guess, standard high
`cholesterol just can't tolerate some statins?
` A. I mean, we don't use "standard high
`cholesterol" as a medical term.
` Q. Okay.
` A. But it's fair to say that there are
`patients who can't tolerate statins, yes.
` Q. I'm going to jump ahead to paragraph
`23. I'm going to hand you what's been marked
`Penn Exhibit 2078.
` Do you recognize this document?
` A. I do.
` Q. Okay. In the first sentence of
`paragraph 23 of your declaration, you indicated
`it was discovered in these CV145-002 clinical
`studies that lomitapide causes severe
`gastrointestinal side effects; do you see that?
` A. Yes.
` Q. This document that I just handed you,
`Exhibit 2078, is related to the trial clinical
`study CV145-002.
` A. Yes, I believe so.
` Q. Were you involved at all in
`CV145-002?
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` DANIEL J. RADER, M.D.
` A. No.
` Q. So now, in your declaration, you
`reference Exhibit 2078 as being a true and
`accurate copy of the BMS-201,038 Investigative
`Brochure General Addendum.
` A. Uh-hum.
` Q. When did you become aware of the
`clinical studies CV145-002?
` MR. JAMES: Dr. Rader, you
` should take whatever time you need to look
` at your declaration in order to answer any
` of these questions.
` THE WITNESS: Okay. Maybe I'll
` read over paragraph 23.
` I don't remember specifically
` when I became aware of that study.
`BY MR. CASIERI:
` Q. Well, did you become aware of it at
`or around the time that you were preparing this
`declaration or sometime prior to when you were
`preparing the declaration?
` A. I became aware of these results prior
`to the preparation of the declaration.
` Q. Do you know about when you might have
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` DANIEL J. RADER, M.D.
`become aware of the results of the studies of
`CV145-002?
` A. It's difficult to give a specific
`date or year. I was aware of these results
`prior to the design of our phase 2 trial in
`HoFH patients. That puts it at least at a
`certain point in time.
` Q. Your phase 2 trial in the HoFH
`patients, do you remember about what time or
`what date that took place?
` A. I have to refresh my memory by
`looking at the declaration.
` Q. Sure.
` A. So I'm going to read from paragraph
`36. By at least December 2nd, 2002, I had
`developed a clinical protocol for a phase 1/2
`open-labeled, dose-escalation study in patients
`with HoFH.
` Paragraph 42, on March 30th,
`2003, I received a communication from the IRB
`noting that it was approved.
` Paragraph 43, the first patient
`received the first dose during the week of
`June 30th, 2003, and the study was complete on
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` DANIEL J. RADER, M.D.
`January 18, 2004.
` Q. Okay. Just so I'm clear, you were
`aware of the results of the clinical studies of
`CV145-002 prior to developing the clinical
`protocol for your tests of HoFH patients?
` A. Correct.
` Q. Okay. Let's get these out, I guess.
`I'm going to hand you what's been marked as
`Exhibit 2077.
` Is that the clinical protocol
`for the trial that you just mentioned with
`regard to paragraph 36?
` A. Yes, it is.
` Q. Okay. So let's take a look back at
`paragraph 23 for a minute.
` The information that you have in
`paragraph 23, and I won't read it all into the
`record, but that information, did that come
`from your memory, or did it come from you
`reviewing Docket Exhibit 2078?
` A. I don't recall.
` Q. As you're sitting here today, do you
`know if all the information in this paragraph
`is accurate?
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` DANIEL J. RADER, M.D.
` A. Well, I could certainly take the time
`to look at this paragraph and compare it to
`what other data we have.
` Q. When you say you don't recall, did
`you prepare this declaration?
` A. I did, I had substantial input into
`the preparation and editing of this document,
`yes.
` Q. Do you have any reason to believe
`that the information contained in paragraph 23
`is inaccurate?
` A. I have no reason to believe that it
`would be inaccurate, no.
` Q. Okay. Could you open it up to, open
`up the Exhibit 2078 to page 204.
` A. Yup.
` Q. In the middle there of the middle
`paragraph, the first sentence indicates, in
`this protocol, 36 hypercholesterolemic healthy
`volunteers were recruited in four groups of
`nine subjects each to receive in an ascending
`fashion doses of BMS-201,038 of 10, 25, 50 or a
`hundred milligrams were matched placebo
`capsules QD for 14 days; do you see that?
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` DANIEL J. RADER, M.D.
` A. Yes.
` Q. Do you know what they mean by
`ascending fashion doses?
` A. That's a term in drug development in
`which different groups of patients are given
`doses of the drug in an ascending fashion;
`meaning, one group gets one dose, the next dose
`gets a higher dose, the next group gets a
`higher dose.
` Q. So no subjects are receiving 10, then
`25, 50?
` A. No.
` Q. They're receiving one dose and only
`one dose?
` A. Correct.
` Q. You say in your declaration, still in
`paragraph 23, about time and dose related
`decrease in LDL cholesterol was observed all
`doses cause gastrointestinal side effects with
`more frequent and severe gastrointestinal side
`effects at higher doses, so that includes the
`10-milligram dose; do you know?
` MR. JAMES: Objection to the
` form.
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` DANIEL J. RADER, M.D.
` THE WITNESS: The abbreviated
` clinical study report, it doesn't
` specifically touch on the 10 milligram.
`BY MR. CASIERI:
` Q. Okay. Is it fair to say that what
`you know about the results of CV145-002 is
`contained in what's in this report, which is
`Penn Exhibit 2078?
` MR. CASIERI: Objection to the
` form.
` THE WITNESS: At one point I was
` shown data related to this trial that was
` more extensive than what is included in
` this abbreviated study report.
`BY MR. CASIERI:
` Q. And do you remember the data
`concerning the 10 milligram group of patients?
` A. I don't specifically remember.
` Q. Is the 10-milligram dose therapeutic
`or subtherapeutic dose?
` A. Define "therapeutic"?
` Q. Why don't we -- I'll strike that
`question for now.
` Why don't we turn to paragraph
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` DANIEL J. RADER, M.D.
`40 of your declaration. Right in the middle,
`second sentence, actually, you say instead, we
`were evaluating a forced titration regimen that
`required patients to receive an initial very
`low subtherapeutic dose, followed by at least
`three substantially increased doses of
`lomitapide to confirm that this forced dose
`titration would reduce side effects.
` So my question to you is, what
`do you mean there by subtherapeutic dose?
` A. This was a trial in HoFH patients.
`What I mean there is that we expected that that
`dose would have minimal effect in reducing LDL
`cholesterol in these HoFH patients.
` Q. Okay. So, with that definition in
`mind, is the 10-milligram dose a subtherapeutic
`dose?
` MR. JAMES: Objection to form.
` Vague and ambiguous.
` THE WITNESS: I think the answer
` to that question depends on what type of
` patient is being treated.
`BY MR. CASIERI:
` Q. Okay. So, for a 10-milligram dose of
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` DANIEL J. RADER, M.D.
`lomitapide, it could be a therapeutic dose or a
`subtherapeutic dose depending on the patient?
` A. Yes.
` Q. Do you know what kind of diet the
`volunteers in CV145-002 were following during
`the trial?
` A. So, reading from the study report,
`all subjects entered for a seven-day dietary
`lead in with an AHA step-one diet, which was
`maintained throughout the study. I can't
`define that specifically for you, but I know
`it's a low fat diet.
` Q. You don't know any other details
`about the AHA step-one diet other than --
` A. Other than the fact that it's a low
`fat diet, no.
` Q. If you wanted to find out about the
`specifics of that diet, what would you do, in
`the specifics of that diet and the time frame
`of this study?
` A. I'm not sure I understand your
`question.
` Q. I'm just trying to figure out -- I'm
`sorry, it's not a trick question or anything.
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` DANIEL J. RADER, M.D.
`I'm just trying to figure out how one would go
`about determining what this AHA step-one diet
`is.
` A. AHA stands for the American Heart
`Association. So I suppose going to the source
`would be -- you have to do that.
` Q. Okay. Do you know if the -- still on
`this Exhibit 2078, do you know if the patients
`on the 10-milligram dose acclimated to the
`drug?
` A. I don't know.
` Q. On page three of four, right in the
`middle of the paragraph there, it says the
`spectroscopic results indicate that in
`comparison with baseline and with placebo,
`there appear to be some increase in hepatic fat
`content at all doses.
` Do you know if there was any
`uncertainty as to whether there was actually
`hepatic fat content in all doses?
` A. Do I know if there was any
`uncertainty, I want --
` Q. Yeah.
` A. Can you repeat the question?
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` DANIEL J. RADER, M.D.
` Q. Yeah.
` A. I want to understand what you're
`asking.
` Q. I'm focusing on the term "there
`appear to be" in that sentence. I'm just
`trying to understand, if you know, do you know
`for sure there was increase in hepatic fat
`content in all doses, or was there some
`uncertainty?
` A. I don't know. We have the data that
`are here.
` Q. Well, let's move onto paragraph 24.
`In the very first sentence, you say, due to my
`prior relationship with Dr. Gregg and
`Dr. Wetterau, I became involved in clinical
`testing conducted by BMS on lomitapide; do you
`see that?
` A. Yes.
` Q. What clinical testing are you
`referring to -- strike that.
` What involvement did you have in
`the clinical testing conducted by BMS of
`lomitapide?
` A. I go on to describe in that statement
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` DANIEL J. RADER, M.D.
`in more detail through my involvement in
`CV145-009. Just reading from the declaration,
`I was one of the clinical trial investigators
`for CV145-009.
` Q. And I'll show you what's been marked
`Penn Exhibit 2080.
` Is this is the clinical trial
`you're referring to paragraph 24 of your
`declaration?
` A. Yes.
` Q. So what is this document?
` A. Well, it's stated on the cover sheet
`an abbreviated clinical study report.
` Q. And was Dr. Gregg and Dr. Wetterau
`working at BMS at the time that you were
`involved in this clinical study?
` A. Yes, to the best of my knowledge,
`yes, uh-hum.
` Q. And where were you working at the
`time?
` A. I was at University of Pennsylvania.
` Q. You were at a study site at this
`clinical trial?
` A. I was.
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` DANIEL J. RADER, M.D.
` Q. How much interaction did you have
`with Dr. Gregg and Dr. Wetterau?
` A. Specific to this clinical trial?
` Q. Yeah.
` A. Dr. Wetterau, none. Dr. Gregg,
`essentially, none as well. He had no direct
`role in running this trial for BMS, if my
`memory serves.
` Q. You had worked with either Dr. Gregg
`or Dr. Wetterau prior to that?
` A. I had worked with Dr. Gregg when we
`were both at the NIH, where he left to join
`BMS.
` I mostly knew Dr. Wetterau
`through scientific meetings.
` Q. Did anyone at BMS ever mention
`concerns about lomitapide causing
`phospholipidosis?
` MR. JAMES: Objection to the
` form. Vague as to time.
` THE WITNESS: Could you clarify
` when that might have been?
`BY MR. CASIERI:
` Q. Yes, at any time prior to 2005.
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` DANIEL J. RADER, M.D.
` A. Yes.
` Q. Who mentioned concern about
`phospholipidosis?
` A. I don't remember.
` Q. Do you remember anything about the
`conversation with the person who mentioned a
`concern about phospholipidosis?
` A. I don't have a specific memory of a
`conversation. But I do have a memory of the
`fact that it was a concern, which was the
`reason we included pulmonary function tests and
`spirometry in this clinical protocol.
` Q. And do you know what the results of
`the pulmonary function test and spirometry
`were?
` MR. JAMES: Objection. Which
` clinical trial are you referring to in
` that question?
` THE WITNESS: Should I assume
` that you're referring to the '09 trial
` that we've been discussing that we have in
` front of us?
` MR. CASIERI: Yes. Counsel,
` you're supposed to object to the form.
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` DANIEL J. RADER, M.D.
` You know, we're not having a conversation.
` MR. JAMES: Ask a clear question
` and I won't object.
` MR. CASIERI: No, just object to
` the form. If I don't think it's clear,
` I'll reword it.
` MR. JAMES: I'm making the
` objections which I think are appropriate.
` MR. CASIERI: That's not an
` objection. You asking me about my
` question is not an objection.
` MR. JAMES: It is an objection.
` MR. CASIERI: No, it isn't.
` MR. JAMES: Just ask questions.
` THE WITNESS: So I'm looking at
` the clinical study report to see if
` there's any mention specifically of the
` pulmonary function test and spirometry. I
` don't see any mention in this report of
` those safety testing results.
`BY MR. CASIERI:
` Q. Do you have any recollection yourself
`of the results of those safety testing at your
`own study center?
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` DANIEL J. RADER, M.D.
` A. No, I don't.
` Q. So my next question is, did anyone at
`BMS ever mention any concerns about lomitapide
`causing hERG inhibition prior to 2005?
` A. I don't have a specific memory of
`that having been mentioned.
` Q. Are there any particular tests in the
`protocol that would lead you to believe that
`that was a concern?
` MR. JAMES: Objection. Vague.
` THE WITNESS: And you're talking
` about the '09 protocol, correct?
`BY MR. CASIERI:
` Q. Correct.
` A. I don't see a specific description of
`it. But a study like this would be expected to
`have included in ECG or multiple ECGs, but I
`don't see it specifically mentioned in this
`study report.
` Q. An ECG test would uncover hERG
`inhibition; is that fair to say?
` A. It's not a specific test for hERG
`inhibition, but it's a test for QT
`prolongation.
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` DANIEL J. RADER, M.D.
` Q. If you would turn to page two of
`Exhibit 2080. Towards the bottom, there's a
`section starting with methodology; do you see
`that?
` A. Yup.
` Q. And the very first center, actually,
`second sentence, after adherence to a low fat,
`low cholesterol diet conforming to the National
`Cholesterol Education Program step-one diet for
`at least two weeks; do you see that?
` A. I do.
` Q. Is that the same diet that we were
`discussing before with regard to your earlier
`clinical trial CV145-002?
` A. Well, what it says here is NCEP
`step-one diet. The other one said AHA step-one
`diet. And, frankly, I don't -- I don't know
`the --
` Q. The first sentence, it says, after
`adherence to a low fat, low cholesterol diet
`for at least two weeks and no treatment with
`lipid-lowering agents for a minimum of four
`weeks, subjects entered into a four-week,
`single-blind placebo lead-in period, period A;
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` DANIEL J. RADER, M.D.
`do you see that?
` A. Uh-hum.
` Q. Do you know if they were on a special
`diet during the testing phase?
` A. Define "testing phase," just so I
`understand?
` Q. Do you know if they were --
` A. Taking the placebo or taking the
`lomitapide?
` Q. Taking the lomitapide.
` A. Yes, the answer is, yes, the -- the
`idea is to put them on the low fat diet and
`leave them on that diet throughout the course
`of that study.
` Q. What is a four-week, single-blind
`placebo lead-in period?
` A. I believe what that refers to in this
`context of this trial is that all the study
`subjects were placed on a placebo for four
`weeks where they didn't know they were
`receiving placebo, but the investigators did,
`hence the term single blind.
` Q. So when did they receive the drug?
` A. Let me just refresh my memory here on
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` DANIEL J. RADER, M.D.
`the methodology.
` After successful completion of
`dietary and placebo lead-in, subjects were
`randomized in a one-to-one ratio to receive
`once daily doses of BMS-201,038 for matched
`placebo. So, essentially, at the end of the
`four-week, single-blind placebo period they
`were randomized to either lomitapide or
`placebo.
` Q. Just so I am clear, do you know any
`specifics of the NCEP step-one diet?
` A. I don't, no.
` Q. And the subjects in CV145-009, did
`they have HoFH?
` A. No.
` Q. Did they have hypercholesterolemia?
` A. They had an LDL cholesterol greater
`than 160 milligram per deciliter, which would
`be conventionally considered to be
`hypercholesterolemia.
` Q. Okay. Let's take a look at 30,
`paragraph 30, of your declaration. I'm just
`going to read the first sentence there:
`Despite the major GI side effects -- GI is
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` DANIEL J. RADER, M.D.
`gastrointestinal side effects?
` A. Yes.
` Q. -- an increase in hepatic fat with
`lomitapide seen in study CV145-009. I believe
`the dramatic clinical efficacy in LDL-C
`reduction of lomitapide may have viable
`molecule for potential further development for
`use in patients with HoFH where the unmet
`medical need was substantial.
` Did I get that right?
` A. Yes.
` Q. What was it that made you -- strike
`that.
` After your experience with
`CV145-009, did you believe that there was
`potential to treat non-HoFH patients with
`lomitapide?
` A. Lomitapide reduced LDL cholesterol
`substantially in that -- in that study which
`was in as we discussed non-HoFH patients, but
`it also had major side effects and toxicities,
`making its further clinical development in the
`non-HoFH setting extremely challenging.
` Q. So what was it about the HoFH
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` DANIEL J. RADER, M.D.
`patients that made you think lomitapide would
`be a viable molecule for potential further
`development?
` A. HoFH is a very severe form of
`hypercholesterolemia. As I state here, the
`unmet medical need at the time was substantial
`and the risk of heart attack, stroke and death
`was very high, so I felt that it may be a
`condition where lomitapide might be acceptable
`despite its side effects and toxicities.
` Q. And at that time, did you consider
`any other MTP inhibitors for potential further
`development for use in patients with HoFH?
` A. I don't recall.
` Q. So, in paragraph 31, you indicate
`that after the termination of lomitapide
`development by BMS, I approached BMS with the
`idea of donating the molecule to Penn so that
`we could test it in patients with HoFH for
`which there were no efficacious cholesterol
`treatments; do you see that?
` A. Yes.
` Q. Did you specifically tell BMS that
`you only wanted to test it on HoFH patients?
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` A. I don't specifically recall my
`initial communication, but I was clear that the
`first study I wanted to do, if they were
`willing to transfer the molecule, was in
`patients with HoFH.
` Q. Do you know if BMS was trying to
`treat any patients with HoFH, trying to develop
`a drug to treat patients with HoFH?
` A. At what time period?
` Q. When you approached them about
`donating the molecule to Penn.
` A. Are you asking if they were trying to
`treat HoFH with lomitapide or with any drug?
` Q. With any drug.
` A. With regard to lomitapide, I don't
`believe they had any plans to treat HoFH. With
`regard to another drug, I really don't know.
` Q. Now, at the time you approached BMS,
`were an at all